NCT07184749

Neurocognitive and Psychological Impact of Chemotherapy in Breast Cancer Patients: A Prospective Observational Study

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Sohag University · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Despite growing awareness of neurocognitive and psychological complications of systemic chemotherapy administration in breast cancer, prospective observational studies evaluating such effects in Egyptian breast cancer patients-especially with pre- and post-treatment assessments-remain limited. Given the rising incidence of breast cancer in Egypt and the growing population of long-term survivors, it is essential to investigate the extent and nature of cognitive and psychological changes associated with treatment. The current study aims to fill this gap by prospectively evaluating neurological, cognitive, and psychological parameters in newly diagnosed breast cancer patients, using validated tools before and one year after treatment.

Detailed description

Patient Recruitment This prospective observational study will include female breast cancer patients who will be recruited from the neuropsychiatry, Clinical Oncology, and general surgery departments, as well as from outpatient clinics at Sohag University Hospital. Inclusion Criteria Female patients with newly diagnosed breast cancer will be included. All patients will be evaluated before the initiation of treatment and again one year after treatment completion. Study Methodology All enrolled patients will undergo the following assessments: Complete History taking: thorough medical, neurological, and oncological history will be obtained, including comorbidities and current medications. Neurological Examination: Each patient will receive a comprehensive clinical neurological examination at baseline and one year after treatment. Neuroimaging: Brain MRI will be performed to detect any structural brain abnormalities or metastatic lesions. Neurophysiological Assessment Nerve conduction studies (NCS) will be conducted to evaluate for peripheral neuropathy. Cognitive Function Assessment Cognitive testing will be carried out at baseline and at the one-year follow-up using the following tools: A. Wisconsin Card Sorting Test (WCST) This test will assess executive functions such as cognitive flexibility and set shifting. Higher perseverative error scores will indicate poorer performance (7). B. Trail Making Test (TMT), Parts A \& B Part A: Patients will connect sequential numbers to assess visual attention and processing speed. Part B: Patients will alternate between numbers and letters (1-A-2-B…) to assess executive functioning. Errors will be corrected by the examiner in real time (8). C. Montreal Cognitive Assessment (MoCA) This test will evaluate attention, memory, language, executive functions, visuospatial skills, and orientation. Total score: 0-30, with higher scores indicating better function. (Nasreddine et al., 2005)

Conditions

• Breast Cancer
• Chemotherapy-induced Peripheral Neuropathy

Timeline

• Start date: 2025-10-01
• Primary completion: 2026-08-01
• Completion: 2026-09-01
• First posted: 2025-09-22
• Last updated: 2025-09-22

Locations

1 site across 1 country: Egypt